Blog
RSS FeedPosted by Michael Wonder on 13 Apr 2021
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...
Posted by Michael Wonder on 13 Apr 2021
Avenue Therapeutics announces that the FDA is still reviewing its NDA resubmission for IV tramadol
13 April 2021 - The FDA has not provided a decision regarding the new drug application. ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 12 Apr 2021
Cavazzoni to take over influential spot atop FDA drug center
12 April 2021 - Patrizia Cavazzoni has been named the permanent leader of the FDA’s Center for Drug Evaluation and ...
Posted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August. ...
Posted by Michael Wonder on 12 Apr 2021
FDA approves Xolair (omalizumab) pre-filled syringe for self-injection across all indications
12 April 2021 - Xolair for self-injection offers health care providers and appropriate patients another administration option for more flexibility in ...
Posted by Michael Wonder on 12 Apr 2021
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of Duchenne muscular dystrophy
12 April 2021 - FibroGen announced that the U.S. FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, ...
Posted by Michael Wonder on 10 Apr 2021
Scilex has received from FDA a sNDA approval for ZTlido label expansion
9 April 2021 - Scilex has received a supplemental new drug application approval from the FDA for ZTlido to make ...
Posted by Michael Wonder on 09 Apr 2021
Pfizer requests FDA clearance for vaccine in kids ages 12 to 15
9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...
Posted by Michael Wonder on 09 Apr 2021
FDA authorises marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer
9 April 2021 - Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance. ...
Posted by Michael Wonder on 09 Apr 2021
Genmab and Seagen announce U.S. FDA filing acceptance for priority review of tisotumab vedotin biologics license application for patients with recurrent or metastatic cervical cancer
9 April 2021 - BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical ...
Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...
Posted by Michael Wonder on 08 Apr 2021
Immutep achieves fast track designation from US FDA for EFTI, a soluble LAG-3 protein, in first-line recurrent/metastatic head & neck cancer
8 April 2021 - Fast track was granted based on the promising data package from Immutep, including from Immutep’s Phase ...
Posted by Michael Wonder on 08 Apr 2021
Dying patients wait in vain after Trump-era easing of drug law
6 April 2021 - Companies hold back experimental medications from those who want them most. They say they have good reasons, ...
Posted by Michael Wonder on 07 Apr 2021
FDA approves new dosing regimen for cetuximab
7 April 2021 - On 6 April 2021, the FDA approved a new dosage regimen of 500 mg/m2 as a ...